Italian Translation and Validation of the Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire: an Observational, Multicentric, Cross-sectional, 6-months Duration Study on 200 Consecutive Parkinson's Disease Patients.

NCT06406374 | Recruiting

• 1 other identifier: 0068862
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's disease (PD) has been traditionally considered a movement disorder. In fact, it is now recognized as a multisystemic disease involving not only the central nervous system and presenting with a constellation of motor and non-motor features. While the dopaminergic therapy used to control motor symptoms can lead to the development of motor fluctuations, characterized by wearing-off, ON-OFF phenomenon, delayed-ON, dose failure, and dyskinesias, it has been demonstrated that also many non-motor symptoms can have daily fluctuations, according to the response to dopaminergic therapy. Therefore, non-motor symptoms may fluctuate in parallel with motor symptoms and their relationship to plasma dopamine concentration, although the exact mechanism of non-motor fluctuations (NMF) remains speculative. Non-motor features tend to worsen during disease progression and prove to severely impact the quality of life of patients, sometimes more than motor symptoms. The Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire is a patient-derived and self-administered questionnaire, recently developed and validated by the International Parkinson and Movement Disorder Society (MDS), that identifies and quantifies the severity of static and fluctuating non-motor symptoms in people with PD. The NoMoFA scale is constituted of a total of 27 items investigating several non-motor features, such as fatigue (the most reported), sleepiness, and confusion. Considering the self-administered nature of the scale, patients must understand the questions, and it should be available in the patient\'s native language. However, the NoMoFa has not yet been translated into the Italian language. Considering that NoMoFA is a relevant scale in the assessment of patients with PD, we believe it is important to perform a translation and cross-cultural adaptation of the NoMoFA questionnaire in Italian, following the scales translation protocol from the international movement disorders society (MDS), and to analyze the reliability and construct validity of the translated scale in Italian patients with PD who experience non-motor fluctuations. The aim of the study is to translate and validate the adapted Italian version of NoMoFA questionnaire.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Non-motor fluctuations; NoMoFA

Outcome Measures

Primary Outcomes (1)

• Non-motor fluctuations assessment

  The aim of this study is to validate an Italian version of NoMoFA scale for the evaluation of non-motor symptoms fluctuations.

  The entire project is planned for a duration of 13 months.

Study Arms (1)

Parkinson's disease patients

Patients will present the following inclusion criteria: * Diagnosis of idiopathic Parkinson's disease according to the 2015 Movement Disorders Society (MDS) criteria (Postuma et al. Mov Dis, 2015); * Italian speaker; * Mini-mental state examinations (MMSE) score \>25; * Presence of symptoms fluctuations, as per a Wearing-off questionnaire 19 (WOQ-19) score\>=2; * Stable antiparkinsonian medications for at least three months; * Ability to provide informed consent.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will enroll 200 consecutive patients with a diagnosis of idiopathic Parkinson\'s disease according to validated clinical criteria and experiencing symptoms fluctuations, as per a Wearing-off questionnaire 19 (WOQ-19) score\>=2.

You may qualify if:

• Diagnosis of idiopathic Parkinson\'s disease according to the 2015 Movement Disorders Society (MDS) criteria (Postuma et al. Mov Dis, 2015);
• Italian speaker;
• Mini-mental state examinations (MMSE) score \>25;
• Presence of symptoms fluctuations, as per a Wearing-off questionnaire 19 (WOQ-19) score\>=2;
• Stable antiparkinsonian medications for at least three months
• Ability to provide informed consent.

You may not qualify if:

• Atypical Parkinsonian syndrome
• H\&Y\>4
• Patients under legal protection

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

Dipartimento di Neuroscienze e Salute Mentale SC Neurologia 2U

Torino, TO, 10126, Italy

RECRUITING

Related Publications (1)

• Kleiner G, Fernandez HH, Chou KL, Fasano A, Duque KR, Hengartner D, Law A, Margolius A, Poon YY, Saenz Farret M, Saleh P, Vizcarra JA, Stebbins GT, Espay AJ; PSG NoMoFA Study Group. Non-Motor Fluctuations in Parkinson's Disease: Validation of the Non-Motor Fluctuation Assessment Questionnaire. Mov Disord. 2021 Jun;36(6):1392-1400. doi: 10.1002/mds.28507. Epub 2021 Feb 15.

  PMID: 33590555 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Carlo Alberto Artusi, MD, PhD

CONTACT

+390116709366; carloalberto.artusi@unito.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: April 26, 2023
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

IT (1)